Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
Innovative Research in Cancer Nanotechnology (IRCN) (R01 Clinical Trial Not Allowed)
Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-17-240 - Innovative Research in Cancer Nanotechnology (IRCN) (R01)

Related Notices

August 26, 2020 - Notice of Correction to Eligibility in NIH Funding Opportunity Announcements. See Notice NOT-OD-20-171.

Funding Opportunity Announcement (FOA) Number
PAR-20-284
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.394; 93.395

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) entitled "Innovative Research in Cancer Nanotechnology (IRCN)" encourages applications promoting transformative discoveries in cancer biology and/or oncology through the use of nanotechnology. Proposed projects should address major barriers in cancer biology and/or oncology using nanotechnology and should focus on mechanistic studies to expand the fundamental understanding of nanomaterial and/or nano-device interactions with biological systems. These studies are expected to be relevant to the delivery of nanoparticles and/or nano-devices to desired and intended cancer targets in vivo and/or characterization of detection and diagnostic devices and sensors in vitro. IRCN awards are expected to produce fundamental knowledge to aid future and more informed development of nanotechnology-based cancer interventions.

Key Dates

Posted Date
August 13, 2020
Open Date (Earliest Submission Date)
October 04, 2020
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

 

November 4, 2020, May 6, 2021, November 4, 2021, May 5, 2021, November 3, 3022, May 4, 2023

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

February/March 2021; August/September 2021; February/March 2022; August/September 2022; February/March 2023; August/September 2023

Advisory Council Review

May 2021; January 2022; May 2022; January 2023; May 2023; January 2024

Earliest Start Date

July 2021; April 2022; July 2022; April 2023; July 2023; April 2024

Expiration Date
May 05, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this funding opportunity announcement (FOA) entitled "Innovative Research in Cancer Nanotechnology (IRCN)" is to expand the fundamental understanding of the processes pertinent to the use of nanotechnology in cancer. The goal of IRCN projects is to conduct mechanistic studies and generate new fundamental knowledge associated with the development of nanotechnology-based solutions to major problems in cancer biology and/or oncology. IRCN awards are expected to produce fundamental knowledge to aid future and more informed development of practical nanotechnology-based cancer interventions (although prospective clinical translation of the IRCN findings remains beyond the scope of this FOA). Projects supported by the IRCN initiative will incorporate multi-disciplinary research in biology/oncology, chemistry, physics, and/or engineering.

Nanotechnology in the context of this FOA. To be responsive to this FOA, the proposed nanotechnology approaches, materials, devices, and technologies should meet the following criteria:

  • The functional or active component(s) of devices or base materials either fabricated, assembled, or synthesized, must be at dimensions of 300 nm or less;
  • Materials used and/or proposed to be developed must be either synthetic or biologically-based materials that are engineered to provide novel properties or modified functions due to their controlled assembly or synthesis at the nanoscale.

Background

Potential of nanotechnology in cancer research and oncology. Significant progress has been made in the synthesis and characterization of engineered nanoparticles and nano-devices for diagnosis and treatment of cancers and a few cancer nanotechnology strategies have already moved into clinical trials and obtained FDA approval. However, these strategies produced only modest improvement in treatment efficacy and/or early diagnosis capabilities. In order to improve the effectiveness of nanotechnology-based cancer interventions and gain their broader acceptance, further systematic and mechanistic studies on a fundamental understanding of nanomaterial and/or nanodevice interactions with biological systems are needed.

NCI has been supporting the development of nanotechnology for cancer prevention, diagnosis, and treatment using a wide range of funding mechanisms (http://nano.cancer.gov). The information on general areas of research interest and status of these activities can be found in the following documents:

It is recognized that further investigations into the fundamental understanding of interactions between nanoparticles and/or nano-devices and biological systems are a key to informed and successful technology translation.

Research Objectives for IRCN Awards

General Expectations for IRCN Projects. IRCN awards are expected to advance employment of nanotechnology in understanding, diagnosing, and treating neoplastic diseases. Each proposed IRCN project is expected to generate new fundamental knowledge aiding the development of nanotechnology-based solutions to major problems in cancer biology and/or oncology. Typical efforts and applications in this area of research involve 1) demonstration of therapies based on nanoparticle delivery with the attempt to obtain improved efficacy and 2) demonstration of diagnostic tools (in vitro or in vivo) with improved sensitivity and specificity. These are clearly important objectives, but it is often that the above goals can be accomplished without a full understanding of the therapeutic mode of action or insight into mechanisms contributing to improved sensitivity and specificity of diagnostics. Projects submitted to this FOA need to be designed differently. While proposing an innovative, nanotechnology-based solution to cancer biology and/or oncology problems, the project should focus on mechanistic studies. These studies are expected to address the fundamental understanding of nanomaterial and/or nano-device interactions with biological systems in the effort to uncover mechanisms governing effective delivery of nanoparticles and/or nano-devices to desired and intended cancer targets in vivo and/or successful operation of detection and diagnostic devices and sensors in vitro. The innovative use of nanotechnology to solve cancer biology/oncology problems is viewed as more significant than innovation in nanotechnology itself (e.g., development of new nanomaterials).

Possible Research Directions. Examples of appropriate research areas are listed below. These examples are not meant to be comprehensive. Additional research foci are also encouraged, providing they are consistent with the general expectations stated above.

  • Understanding nanoparticle delivery mechanisms and implications of systemic distribution;
  • Understanding intracellular trafficking of nanoparticles;
  • Increasing understanding and refinement of next-generation nanosystem designs;
  • Tools to interrogate and understand cell signaling resulting from tumor progression and/or its treatment;
  • Progression and/or therapy;
  • Techniques and tools to overcome the failure of therapy and therapeutic resistance;
  • Tools and devices aimed specifically at monitoring and understanding the tumor microenvironment;
  • Technologies for cancer molecular targeting and discovery;
  • Devices and tools capable of penetrating cellular and/or physiological barriers;
  • Tools for improved effectiveness of cancer immunotherapies;
  • Tools to understand and minimize immune-related adverse effects (irAEs) of cancer
  • immunotherapies;
  • Development of approaches for effective delivery of nucleic acid therapies;
  • Development and understanding of nanoparticle-based radiation therapies and dosimetry;
  • Development of improved multi-biomarker detection elucidating previously unknown cancer biology and based on diagnostic devices and sensors;
  • Design of sensitive and specific imaging agents and theranostics;
  • Integration of modeling and simulation approaches to guide rational nanomaterial design.

Tumor Types. All IRCN applicants are expected to concentrate their proposed efforts on one or two rationally selected tumor types. For this FOA, a "tumor type" refers to either tumors of a specific tissue of origin or tumors with critical abnormalities in a particular molecular pathway(s) shared in cancers arising from a variety of tissues.

Annual Principal Investigators' Meeting

NCI holds an annual meeting of investigators funded through the institute's nanotechnology programs with the purpose of sharing research progress and establishing collaborations. All investigators supported by this FOA are expected to attend this two-day meeting organized by NCI each year.

Non-responsive Applications

This FOA will NOT support projects that:

  • Propose only the use of naturally-occurring materials (e.g., polysaccharides, proteins, viruses) that are not specifically engineered or modified for the intended function;
  • Involve clinical trials or in vivo studies in human subjects;
  • Focus on nanotechnology solutions for AIDS/HIV even in the context of cancer.

Additional Available Resources

Applicants are encouraged to consider using, as appropriate, various relevant NCI-supported resources described below.

  • Nanomaterials characterization. The NCI recognizes that further development of nanotechnologies for oncology purposes will benefit greatly from a concerted and coordinated effort to characterize the wide range of nanoscale materials and devices. The NCI’s Nanotechnology Characterization Laboratory (NCL; http://ncl.cancer.gov/) provides infrastructure support towards the uniform and consolidated characterization of these materials and devices and aids the translation of nanotechnology-derived cancer therapeutics and diagnostics.
  • Nanotechnology-related informatics. The NCI Center for Biomedical Informatics and Information Technology (CBIIT; http://cbiit.nci.nih.gov/) sponsors the cancer Nanotechnology Laboratory data portal (caNanoLab; https://cananolab.nci.nih.gov/caNanoLab/) and the National Cancer Informatics Program (NCIP) Nanotechnology Working Group (https://wiki.nci.nih.gov/display/ICR/Nanotechnology+Working+Group). caNanoLab is designed to facilitate the sharing of nanomaterials data and to expedite and validate the use of nanomaterials in medicine.
  • Animal models. NCI supports a broad spectrum of animal facility experimental resources under the Laboratory Animal Science Program (LASP; http://ncifrederick.cancer.gov/rtp/lasp/intra/lasp.asp). It also operates the Center for Advanced Preclinical Research (CAPR; https://ccr.cancer.gov/capr) that can conduct an independent preclinical assessment of nanomaterials in vivo in a variety of predictive xenograft and genetically engineered mouse models, as well as syngeneic genetically engineered mouse-derived allografts.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

Resubmission of applications submitted to this FOA and to PAR-17-240

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $450K in direct costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

 

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline the specific goals of the project.

Research Strategy: The proposed project description must consist of the standard sub-sections: Significance, Innovation, and Approach and an additional "Milestones" sub-section (described below).

Significance

Project Scope and Emphasis. The proposed project should emphasize fundamental understanding of mechanisms associated with the use of nanotechnology in solving a cancer-relevant problem. Provide rationale for why the proposed project is expected to produce a significant body of fundamental, mechanistic knowledge relevant to the interactions of nanomaterials and/or nano-devices with biological systems, including aspects relevant to the delivery of nanoparticles and/or nano-devices to desired and intended cancer targets in vivo and/or characterization of detection and diagnostic devices and sensors in vitro.

Innovation

In the Innovation sub-section, provide a comparison of the proposed nanotechnology-based solution of cancer-relevant problem to available or possible classical approaches/options and/or currently used nanotechnology solutions. Discuss how the problem is approached at present and the limitations of current solutions, and how the proposed nanotechnology is expected to overcome these limitations. Summarize the key advantages and innovative aspects of the proposed technology and solution over other options. This comparison should be based on actual data (either investigators’ own preliminary data or literature data).

Approach

In the Approach sub-section, provide information pertaining to the following requirements.

1. Well Developed, Rigorous Project. Proposed projects are expected to be well developed conceptually and, in general, well supported by appropriate preliminary data from investigators’ laboratories.

2. Interaction with the NCI's Nanotechnology Characterization Laboratory (NCL). The investigators are strongly encouraged to work closely with NCL during their project.

3. Selection of Tumor Types. The project may focus, as appropriate and justified, on one or two rationally selected tumor types or types of abnormalities. In selecting specific tumor types, IRCN applicants are strongly encouraged to consider cancers that may strongly benefit from a nanotechnology approach and to take advantage of available resources with catalogs of clinical tumors that have been comprehensively characterized at the molecular genetics level (e.g., by programs such as The Cancer Genome Atlas (TCGA), http://cancergenome.nih.gov/, Therapeutically Applicable Research to Generate Effective Treatments (TARGET), http://ocg.cancer.gov/programs/target, and Cancer Genome Characterization Initiative (CGCI), http://ocg.cancer.gov/programs/cgci). Additionally, applicants should consider the tumor type relative to its existing treatment and/or diagnostic paradigms and how their proposed approach could improve these for the tumor type or respective indication.

4. Selection of Animal Tumor Models. Describe the animal tumor models that you plan to use in the proposed studies.

5. Possible Research Directions. Examples of appropriate research directions are listed in Section I. The list is not meant to be comprehensive and additional directions/topics are also encouraged, providing they fit into the overall goals of IRCN funding opportunity and conform to other requirements. Moreover, the listed examples are NOT mutually exclusive and are NOT meant to confine the scope of a project. Various directions may be combined into a single project, if appropriate.

Milestones

This sub-section is required for all applications. All applicants must describe here a set of discrete benchmarks that will allow unequivocal determination of the progress over time made towards the goals of the project. Milestones should be scientifically justified and well defined for each year of the project and be based on the proposed specific aims. Whenever feasible, milestones should provide quantitative benchmarks for comprehensively assessing the annual progress of the project. Milestones must not be simply a restatement of the specific aims. The specific aims describe the research goals of the project. The milestones should provide the means for assessing the progress made towards each aim and offer a timeline for it. The completion of these milestones will be used to judge the success of the proposed research on an individual-project basis.

Examples of Milestones:

  • Verify that designed composite nanoparticles are capable of reproducible release of its "cargo" at tumor/cancer cell sites in vivo.
  • Ascertain that a new targeted nanoparticle can specifically deliver a therapeutic agent to the tumor by demonstrating “x” times improvement as compared to "free" drug delivery.
  • Demonstrate the ability of a nanoparticle diagnostic construct to detect at least “x” specific proteins in blood (out of “y” specific proteins proposed) at a femtomolar level.
  • Demonstrate the ability of the proposed nanotechnology to achieve 95% rate of capture for circulating tumor cells in blood.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The emphasis and priority of this FOA are on the development of basic or pre-clinical research projects, addressing major barriers in cancer biology and/or oncology using nanotechnology-based solutions. The priority is placed on innovative projects with high potential to generate significant new knowledge relevant to a fundamental understanding of the processes pertinent to the use of nanotechnology in cancer research and care, including interactions of nanomaterials and/or nano-devices with biological systems and aspects relevant to their delivery to the desirable and intended cancer targets in vivo as well as characterization of detection and diagnostic devices in vitro.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

    • How strong is the rationale that the proposed nanotechnology approach may be better than other currently available approaches to solve the proposed cancer biology and/or oncology problem?
    • What is the potential of the proposed project to generate fundamental understanding of the processes pertinent to the use of nanotechnology in cancer research and care?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

  • How innovative is the nanotechnology approach as compared to other available approaches for addressing the cancer biology and/or oncology problem described in the application?
  • What is the innovative potential of the proposed project in terms of overcoming major barriers that currently restrict the effective use of novel nanotechnology solutions towards cancer-relevant problems?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

  • Are the proposed approaches sufficiently supported by convincing preliminary data?
  • Will the study methodologies proposed in the project enable the development of a significant body of new knowledge?
  • Are the proposed multi-disciplinary approaches appropriate and well-matched to the nature of the project, and sufficient to both optimally and comprehensively address project objectives?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones

  • Are the milestones adequately comprehensive and realistic? Will these milestones allow for a sufficiently accurate and informative evaluation of the progress of the project proposed?
  • Are alternative approaches or contingencies adequately described in the context of milestones?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Piotr Grodzinski, Ph.D.
National Cancer Institute (NCI)
Telephone 240-781-3305
Email: grodzinp@mail.nih.gov

Christopher Hartshorn, Ph.D.
National Cancer Institute (NCI)
Telephone 240-781-3315
Email: christopher.hartshorn@nih.gov

Christina Liu, Ph.D.
National Cancer Institute (NCI)
Telephone 240-781-3348
Email: christina.liu@nih.gov

Peer Review Contact(s)

Mark Caprara, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-827-3076
Email: capraramg@mail.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
240-276-6277
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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